FDA 510(k) Application Details - K111481

Device Classification Name Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

  More FDA Info for this Device
510(K) Number K111481
Device Name Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Applicant CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
Other 510(k) Applications for this Company
Contact LUCINDA GERBER
Other 510(k) Applications for this Contact
Regulation Number 888.3353

  More FDA Info for this Regulation Number
Classification Product Code OQI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/27/2011
Decision Date 02/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact